A significant shift in leadership has occurred at the Center for Devices and Radiological Health (CDRH) within the Food and Drug Administration (FDA). Douglas Kelly, who held the position of deputy center director for science, announced his immediate resignation via a LinkedIn post. This departure follows a series of recent changes in key personnel at the CDRH, raising questions about the stability and direction of the organization. During his tenure, Kelly played a crucial role in shaping policies and programs that impacted the medical device industry. His contributions included negotiating a major user fee agreement and establishing innovative advisory programs to streamline device development. The timing of his exit coincides with broader staffing challenges at the agency, including recent departures and reinstatements of other key figures.

Kelly joined the CDRH in 2020 after transitioning from a career in venture capital. He initially reported to Jeff Shuren, the former director, before Michelle Tarver took over as the leader of the device center in October. One of Kelly's most notable achievements was overseeing the negotiation of the latest user fee agreement, which will allow the FDA to collect up to $1.9 billion in fees from the medical device sector between 2023 and 2027. This agreement is critical for funding the agency's operations and ensuring timely reviews of new devices.

Beyond financial negotiations, Kelly was instrumental in launching the Total Product Lifecycle Advisory Program. This initiative enables developers of breakthrough medical devices to engage earlier with FDA review teams and external stakeholders, fostering a more collaborative approach to product evaluation. Additionally, Kelly focused on attracting top talent to the FDA, recruiting industry leaders such as Ross Segan and Troy Tazbaz. Segan joined as director of the Office of Product Evaluation and Quality, while Tazbaz led the Digital Health Center of Excellence. However, both individuals have since left the agency under different circumstances, with Tazbaz departing in late January and Segan being part of a wave of layoffs targeting probationary employees.

The CDRH has faced internal turmoil, particularly concerning the retention of staff. Some of the employees who were let go have been reinstated, but the future of others remains uncertain. Despite attempts to stabilize the workforce, the FDA and the Department of Health and Human Services have not provided clear answers regarding Kelly’s departure or the status of those affected by recent staffing changes. As the CDRH continues to navigate these challenges, the agency's ability to maintain its regulatory oversight and innovation support will be closely watched by stakeholders in the medical device industry.

Kelly's resignation marks another pivotal moment in the evolving leadership landscape at the CDRH. His contributions have left a lasting impact on the agency's policies and programs, particularly in advancing the development of medical devices. While the reasons behind his decision remain unclear, his legacy includes strengthening the FDA's relationship with the medical device industry and fostering an environment conducive to innovation. Moving forward, the CDRH will need to address ongoing staffing issues to ensure continuity and effectiveness in its mission.